Exercise in Adolescents With Type 1 Diabetes

NCT04418869 | Unknown

• 1 other identifier: 251981
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

Regular physical activity is an important part of diabetes management in adolescents with type 1 diabetes (T1D). Increased physical activity has several beneficial effects such as improved lipid profile, insulin sensitivity and quality of life. In addition, a reduced HbA1c is often seen in association to increased physical activity. However, the effect on glycemic control and the acute glycemic response seems to differs between different types of exercise. This issue is poorly studied in adolescents with T1D and the mechanism behind this is not fully understood. The primary aim of this study was to compare the acute effects on glycemia of resistance and two aerobic continuous and intermittent exercise bouts in adolescents with type 1 diabetes. Secondarily, the investigators want to compare the different exercise according to hormonal changes and expression of mRNA in muscle. At a baseline visit the participants was tested for maximal oxygen consumption (pVO2peak) and maximal strength (1-RM). The study participants then performed three exercise bouts and one control session (resting), each on 45 minutes, in a randomized order. Measurement was performed during and after the exercise.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Exercise; Adolescents

Outcome Measures

Primary Outcomes (1)

• Change in plasma glucose during exercise and recovery

  Plasma glucose (mmol/l) measured by an hand-held glucometer

  Plasma glucose were measured at 5 minutes before and at start of the bouts. Thereafter glucose was measured at 5,10,15,30 and 45 minutes during exercise. In addition glucose were measured at 15, 30, 45 and 60 minutes during the initial recovery period.

Secondary Outcomes (7)

• Sensor glucose

  Blinded continuous glucose measurement was started when the exercise bouts were finished and were there after used during the next 22 hours (until the next morning at 08:00 am).

• Changes in levels of hormones during exercise and recovery

  Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis

• Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.

  One biopsy (baseline) were collected approximately one week before the first exercise bout and thereafter one biopsy appr. 60 minutes after each exercise bout.

• Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.

  One biopsy was collected appr. 60 minutes after each exercise bout.

• Change in heart rate during exercise.

  Heart rate was monitored continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).

Study Arms (1)

Exercise

EXPERIMENTAL

All subject will perform three different exercise bouts and one control session.

Other: Exercise bouts

Interventions

Exercise bouts OTHER

Each subject performed three bouts with 45 minutes of exercise (continuous exercise, intermittent exercise and resistance exercise) in a randomized order. In addition a control session were performed where the subjects sat on a chair for 45 minutes.

Exercise

Eligibility Criteria

• Age: 16 Years - 18 Years
• Gender Eligibility Details: Gender is based on personal identity number and self-identification.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male
• Type 1 diabetes
• Regularly performing physical activity
• Aged 16-18 years old

You may not qualify if:

• Less than 0.5 U/kg in insulin requirements
• Duration of diabetes less than one year.

Sponsors & Collaborators

• Region Örebro County: lead
• Örebro University, Sweden: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Fawzi Kadi, Professor

  School of health Sciences, Örebro University, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: June 5, 2020
• Study Start: March 1, 2014
• Primary Completion: June 27, 2016
• Study Completion: June 1, 2024
• Last Updated: October 31, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share